PHOENIX – Radiofrequency devices, diode lasers, and intense pulsed light devices had the most reports of suspected injuries from 1991 through 2013, based on data from a Food and Drug Administration database.
During that period, 1,212 medical device reports were submitted for suspected injuries from laser or light device use or malfunction to the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database, as well as another 45 that were excluded from the study because of insufficient data. The FDA requires device users and manufacturers to submit the reports and collects voluntary reports from patients. Each report may contain more than one adverse event.
Blisters or burns were the most common problems reported to the MAUDE database for each of the top three devices, Dr. Anne Marie Tremaine and her associates reported at the annual meeting of the American Society for Laser Medicine and Surgery.
Radiofrequency devices were the subject of 270 reports that included 294 adverse events. These reports included 119 burns or blisters; 85 incidents of fat loss, depression, or divot; 34 scars; 25 incidents of dyschromia (both hyper- and hypopigmentation); and 12 cases of sagging skin. In addition, a few reports noted burns in the area of the return pad, paresthesia or nerve palsy, dry eye or "floaters," and cracked dental crowns.
Insufficient coupling fluid and tearing or breakdown in the device tip membrane topped the reasons given for problems related to radiofrequency treatment, reported Dr. Tremaine of Massachusetts General Hospital’s Wellman Center for Photomedicine, Boston. Complications also were ascribed to tumescent anesthesia, intradermal lidocaine injections, and general anesthesia.
The most common treatment modality associated with adverse events was laser hair removal using diode lasers or intense pulsed light. The 252 reports on diode lasers included 297 burns or blisters, 42 incidents of dyschromia, 11 scars, and 8 cases of swelling. The 158 reports on adverse events from intense pulsed light included 126 burns or blisters; 24 incidents of dyschromia; 20 scars; 13 patients with bruising; 12 incidents of fat loss, depression, or divot; and smaller numbers of eye injury or delayed wound healing.
Many of the complications in the reports were attributed to improper settings or improperly maintained device tips.
"Physicians should be aware of the adverse events and malfunctions of the devices used in dermatology," Dr. Tremaine said. The MAUDE database "will help uncover otherwise unreported events seen in routine practice among all types of practitioners" to supplement data from initial studies and reports in the medical literature. This information should help physicians better inform patients about the potential risks of treatment, she said.
Dr. Tremaine and her associates searched the MAUDE database using terms including names of device manufacturers from a comprehensive list, specific product names, and the wavelengths and technology of the devices used in dermatology.
However, because adverse events are underreported to MAUDE, which provides only passive surveillance, the incidence or prevalence of problems with laser or light devices could not be discerned from this database, the investigators noted.
Dr. Tremaine reported having no disclosures.
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